An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.

Genzyme, a Sanofi Company1 site in 1 country40 target enrollmentNovember 2004

ConditionsThyroid Cancer

InterventionsZD6474 (vandetanib)

DrugsZD6474 (vandetanib)

Overview

Phase: Phase 2
Intervention: ZD6474 (vandetanib)
Conditions: Thyroid Cancer
Sponsor: Genzyme, a Sanofi Company
Enrollment: 40
Locations: 1
Primary Endpoint: Objective Response Rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

April 19, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genzyme, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Locally advanced or hereditary medullary thyroid cancer
•Signed informed consent
•One or more measurable lesions

Exclusion Criteria

•Brain metastases or spinal cord compression
•Specific laboratory ranges
•Specific heart problems
•Prior chemotherapy and/or radiation therapy
•Participation in other trials within 30 days

Arms & Interventions

Caprelsa (vandetanib) 300 mg

Daily oral dose of Caprelsa (vandetanib) 300mg

Intervention: ZD6474 (vandetanib)

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.

Secondary Outcomes

Duration of Objective Response(Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.)
Disease Control Rate(Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.)
Biochemical Response Calcitonin (CTN)(Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation)
Symptomatic Response(Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.)
World Health Organisation (WHO) Performance Status(Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.)
Progression Free Survival(Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.)